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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number FORCEFX-8CAS
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Rash (2033); No Code Available (3191)
Date of Event 12/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post-operatively, the patient had a blister and rash in the gluteal fold.Consultation with a cosmetic surgeon recommended continuous local care and there was no indication for antibiotic therapy as long as the erythema does not progress and the patient is apyretic.
 
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Brand Name
FORCE FX
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MEDICAL PRODUCTS
building 10- no 789 puxing roa
shanghai 20111 4
CN  201114
MDR Report Key9717869
Report Number3006451981-2020-00023
Device Sequence Number10851395
Product Code GEI
UDI-Device Identifier10884524002637
UDI-Public10884524002637
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K944602
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFORCEFX-8CAS
Device Catalogue NumberFORCEFX-8CAS
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/31/2020
Initial Report FDA Received Date02/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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